Scandinavian Starch for Severe Sepsis/Septic Shock Trial
Launched by ANDERS PERNER · Aug 18, 2009
Trial Information
Current as of April 29, 2025
Completed
Keywords
ClinConnect Summary
Fluid is the mainstay treatment in sepsis resuscitation, but the effects of different crystalloid and colloid solutions on outcome remain unknown.
Previously, a high molecular weight hydroxyethyl starch, HES 200, was used, but this was found to cause acute kidney failure in patients with severe sepsis. As kidney failure is an independent risk factor for death in these patients, HES 200 is not used anymore. In stead a lower molecular weight starch, HES 130, has been developed. Presently, this is the preferred colloid in Scandinavian intensive care units (ICU), but the effects of HES 130 in ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • All adult patients who
- • Undergo resuscitation in the ICU
- • AND fulfillment within the previous 24 hours of the criteria for severe sepsis (SCCM/ACCP)
- • AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)
- Exclusion Criteria:
- The following patients will not be evaluated for inclusion:
- • Age \< 18 years old
- • Previously randomised in the 6S trial
- • Allergy towards hydroxyethyl starch or malic acid
- • Treatment with \> 1000 ml's of any synthetic colloid within the last 24 hours prior to randomisation
- • Any form of renal replacement therapy
- • Acute burn injury \> 10% body surface area
- • Severe hyperkalaemia, p-K \> 6 mM
- • Liver or kidney transplantation during current hospital admission
- • Intracranial bleeding within current hospitalisation
- • Enrollment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
- • Withdrawal of active therapy
About Anders Perner
Anders Perner is a distinguished clinical trial sponsor renowned for his commitment to advancing medical research and improving patient outcomes. With a robust background in critical care medicine, he leads initiatives that focus on innovative trial designs and the integration of cutting-edge technologies in clinical studies. His collaborative approach fosters partnerships between academic institutions and industry stakeholders, ensuring rigorous scientific methodologies are applied to address pressing healthcare challenges. Under his guidance, clinical trials are conducted with an emphasis on ethical standards, patient safety, and the generation of high-quality evidence to inform clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen, , Denmark
Odense, , Denmark
Stavanger, , Norway
Copenhagen, , Denmark
Copenhagen, , Denmark
Copenhagen, , Denmark
Bergen, , Norway
Esbjerg, , Denmark
Herning, , Denmark
Vejle, , Denmark
Copenhagen, , Denmark
Copenhagen, , Denmark
Hillerød, , Denmark
Hjørring, , Denmark
Holbæk, , Denmark
Holstebro, , Denmark
Køge, , Denmark
Næstved, , Denmark
Slagelse, , Denmark
Sønderborg, , Denmark
Helsinki, , Finland
Kuopio, , Finland
Tampere, , Finland
Reykjavik, , Iceland
Tromsø, , Norway
Trondheim, , Norway
Patients applied
Trial Officials
Anders Perner, MD, PhD
Principal Investigator
ICU, Rigshospitalet, University of Copenhagen
Nicolai Haase, MD
Study Director
Rigshospitalet, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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